An Exploratory Proof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics (PK/PD) of Nemolizumab in Adult Participants With Chronic Pruritus of Unknown Origin (CPUO)
Galderma R&D
Summary
The primary objective of this study is to assess the PK/PD relationship of nemolizumab in adult participants aged 18 years or above with chronic pruritus of unknown origin (CPUO) during a 16-week treatment period.
Description
This study is to assess the PK/PD relationship of nemolizumab in adult participants with CPUO. The study will consist of a 2 to 4-week screening period, a 16-week treatment period, and an 8-week follow up period (12 weeks after last study drug injection). Participants will be randomized 4:1 to nemolizumab or placebo. Dosing will be adjusted according to participants body weight ( less than \[\<\] 90 kilograms \[kg\] versus \>= 90 kg). Participation in the study will last up to 28 weeks.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants are eligible to be included in the study only if all of the following criteria apply: 1. Participant must be 18 years of age or older. 2. Participants with chronic pruritus on normal-appearing skin (except for dry skin or excoriations) for at least 6 months before the screening visit. 3. Chronic pruritus considered of unknown origin (i.e., without a clear association to another condition or medication) as assessed by the investigator at baseline. 4. The pruritus must affect at least 4 of the following body areas: left lower limb, right lower limb, l…
Interventions
- Drugnemolizumab
Participants will receive either 30 mg or 60 mg dose of nemolizumab as SC injection.
- DrugPlacebo
Participants will receive matching placebo as SC injection.
Locations (24)
- Galderma Investigational Site (site# 8893)Birmingham, Alabama
- Galderma Investigational Site (#8768)Tucson, Arizona
- Galderma Investigational Site (site# 8636)Fountain Valley, California
- Galderma Investigational Site (site# 8130)Los Angeles, California
- Galderma Investigational Site (#9975)Sacramento, California
- Galderma Investigational Site (site# 8021)San Diego, California